Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study

Depression Clinical Trial

Official title:

Assessing the Impact of Isha Kriya Meditation on Anxiety and Depression - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065476
• Other study ID #: 2021P000359
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2022
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to assess the impact of Isha Kriya, a freely available guided meditation, on mental health - specifically anxiety and depression.

Description:

In 2019, over 15% of the population experienced symptoms of anxiety. This was highest amongst 18-29-year-olds. Amongst these adults, 9.5% experienced mild, 3.4% experienced moderate, and 2.7% experienced severe symptoms of anxiety. About 1 in 6 adults is expected to suffer from depression at some point in their lives. Due to the pandemic, rates of anxiety and depression increased significantly. In December 2020, 42% of people surveyed by the US Census Bureau had symptoms associated with anxiety or depression. This is compared to 11% of adults having similar symptoms from Jan-June 2019. The rapidly diminishing mental health in the general population, especially since the COVID-19 pandemic, has raised the concern for an emerging new pandemic: the mental health pandemic. Mental health leaders and organizations are urging the federal and state authorities to make mental health a top priority and allocate resources to areas including early identification and prevention, establishing integrated health and mental health care to ensure "whole-person" well-being, assuring evidence-based standards of prevention, treatment and care. Meditation has been shown to be effective in reducing symptoms associated with anxiety and depression. A recent study using a meditation called Isha Kriya showed improved perceived stress amongst operating room professionals in one sitting. Isha Kriya is a simple meditation practice (15minutes) that can be done by anyone over 12 years of age. It is offered free globally via in-person sessions, online webinars, and online videos. A meditation which is available electronically and freely could be an attractive option to include in prevention and treatment strategies for anxiety and depression. Furthermore, such intervention is easily scalable and accessible to everyone with access to the internet and if found effective, can be a valuable resource for addressing disparities in access to mental health resources in minority and underserved populations. This study aims to assess the effectiveness of this meditation on reducing symptoms associated with anxiety and depression over 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years
• Interest in Isha Kriya

Exclusion Criteria:

• Low English proficiency
• Not currently residing in United States

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Abbott A. COVID's mental-health toll: how scientists are tracking a surge in depression. Nature. 2021 Feb;590(7845):194-195. doi: 10.1038/d41586-021-00175-z. No abstract available. — View Citation

Gonzalez-Valero G, Zurita-Ortega F, Ubago-Jimenez JL, Puertas-Molero P. Use of Meditation and Cognitive Behavioral Therapies for the Treatment of Stress, Depression and Anxiety in Students. A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 10;16(22):4394. doi: 10.3390/ijerph16224394. — View Citation

Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593. Erratum In: Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added]. — View Citation

Rangasamy V, Thampi Susheela A, Mueller A, F H Chang T, Sadhasivam S, Subramaniam B. The effect of a one-time 15-minute guided meditation (Isha Kriya) on stress and mood disturbances among operating room professionals: a prospective interventional pilot study. F1000Res. 2019 Mar 26;8:335. doi: 10.12688/f1000research.18446.1. eCollection 2019. — View Citation

Saeed SA, Antonacci DJ, Bloch RM. Exercise, yoga, and meditation for depressive and anxiety disorders. Am Fam Physician. 2010 Apr 15;81(8):981-6. — View Citation

Saeed SA, Cunningham K, Bloch RM. Depression and Anxiety Disorders: Benefits of Exercise, Yoga, and Meditation. Am Fam Physician. 2019 May 15;99(10):620-627. — View Citation

Terlizzi EP, Villarroel MA. Symptoms of Generalized Anxiety Disorder Among Adults: United States, 2019. NCHS Data Brief. 2020 Sep;(378):1-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	The weekly compliance questionnaire is a tool which helps the participants to keep a track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency.	Changes from baseline to 6 weeks
Secondary	PROMIS - Anxiety Short Form	PROMIS - Anxiety Short Form1 is an 8 item validated instrument that assesses severity of anxiety. Participants are asked on a scale of 1 (Never) to 5 (Always) on the frequency of occurrence of each negative experience. Overall score is computed based on sum from individual responses.	Changes from baseline to 6 weeks
Secondary	Center for Epidemiological Studies Depression Scale (CES-D-10)	PROMIS - Anxiety Short Form is an 8 item validated instrument that assesses severity of anxiety.; Participants are asked on a scale of 1 (Never) to 5 (Always) on the frequency of occurrence of each negative experience. Overall score is computed based on sum from individual responses.	Changes from baseline to 6 weeks

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